Aims: The purpose of this single centre registry is to assess safety and feasibility of the frequency domain optical coherence tomography (FD-OCT) system during coronary interventions.
Methods and results: Ninety patients with unstable or stable coronary artery disease were included in this study. OCT imaging was performed in a first group of 40 patients (group 1), to evaluate ambiguous/intermediate lesions (24 patients in group 1 had OCT also done post-PCI, for assessment of stent deployment); and in a second group of 50 patients (group 2), to address the adequacy of stent deployment. Therefore, 74 patients underwent FD-OCT after stent implantation. A complex-lesion population was studied (B2 type lesion=72.2% and C type lesion=20.3%). The mean time of a FD-OCT pull-back (from the set up to the completion of the pull back) was 2.1 min and in all but one (99.1%) the procedure was successful. No patients experienced major complications in terms of death, myocardial infarction, emergency revascularisation, embolisation, life-threatening arrhythmia, coronary dissection, prolonged and severe vessel spasm and contrast induced nephropathy. In the ambiguous lesion group, 60% of patients were treated with PCI, whilst in the others, PCI were deferred. In total, 113 deployed stents (33,6% chromium cobalt stent, 66,4% drug eluting stent) were imaged with OCT. OCT findings led to additional interventions in 24 out of 74 patients (32%): 15 had further balloon inflations, nine had additional stent deployment whilst two had both treatments. At clinical follow-up, (4.6 ± 3.,2 months), there were no death, acute myocardial infarctions and cases of stent thrombosis, whilst two patients underwent revascularisation for recurrence of angina.
Conclusions: The present registry shows that FD-OCT is a feasible and safe technique for guidance of coronary interventions. Randomised studies will confirm whether the use of FD-OCT will improve the clinical outcome.